NCT07088822

A Phase 1 Study Evaluating the Safety, Tolerability, and Immunogenicity of V4020 Vaccine in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Medigen, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and immunogenicity of a novel Venezuelan Equine Encephalitis virus (VEEV) vaccine (V4020) for the first time in humans compared to placebo when administered by subcutaneous or intramuscular injection.

Detailed description

The primary objective of the study will be to measure safety. The primary endpoint measures to assess this objective will include but not be limited to * Frequency and nature of adverse events (AEs) reported or observed in participants; * Relatedness between AEs and vaccine administration; * Interventions or therapy required by participants experience vaccine related adverse events; * Resolution or outcome of AEs. Secondary Objectives and Endpoints Two main immunogenicity objectives will be assessed to include the number considered adequately immunized, and the magnitude and durability of titer responses.

Conditions

• Venezuelan Equine Encephalitis
• Venezuelan Equine Encephalitis Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V4020	The V4020 vaccine was prepared using an iDNA® infectious clone that encodes the full-length rearranged genomic RNA downstream from the optimized CMV promoter. Compared to the wild type VEEV, V4020 contains genetic rearrangement within the genomic RNA, with the capsid gene placed downstream from the glycoprotein genes. V4020 also includes attenuating mutations from the VEE TC83 vaccine, nucleotide A at position 3 in the untranslated region and E2-120Arg in the E2 glycoprotein. Notably, the E2-120Arg attenuating mutation was genetically engineered in V4020 to prevent reversion mutations. The E2-120Arg was encoded in V4020 by a CGA codon instead of AGA in the TC83 virus. Therefore, in the V4020 vaccine, at least two mutations would be needed to revert to the wildtype ACA (E2-120Thr). In contrast, in the TC83 vaccine, an AGA codon encodes the attenuating mutation E2-120Arg, and a single point mutation would be sufficient to revert to the 213 VEEV wild type ACA (E2-120Thr).

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-02-28
• Completion: 2026-12-31
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study